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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression Tray, Resin
510(k) Number K905058
Device Name PALAVIT L
Applicant
Kulzer, Inc.
10005 Muirlands Blvd.
Unit G.
Irvine,  CA  92718
Applicant Contact SHARON PARKER
Correspondent
Kulzer, Inc.
10005 Muirlands Blvd.
Unit G.
Irvine,  CA  92718
Correspondent Contact SHARON PARKER
Regulation Number872.3670
Classification Product Code
EBH  
Date Received11/08/1990
Decision Date 06/06/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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